NCT06568705

Brief Summary

The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. The main questions it aims to answer are:

  • Can online adaptive radiotherapy improve the accuracy of dose delivery?
  • In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities and tumor control outcomes? Participants will Receive moderate hypofractionated radiotherapy using online adaptive radiotherapy, a dose of 43.5Gy in 15 fractions or receive ultrafractionated radiotherapy using online adaptive radiotherapy, a dose of 26Gy in 5 fractions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
6mo left

Started Sep 2024

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Sep 2024Dec 2026

First Submitted

Initial submission to the registry

August 21, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

August 21, 2024

Last Update Submit

March 18, 2026

Conditions

Breast Cancer

Keywords

Online Adaptive RadiotherapyBreast CancerHypofractionated Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • The dose coverage of target volume as assessed by planning tumor volume V100%

    Planning tumor volume V100%, defined as the planning tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.

    3 months after radiotherapy

Secondary Outcomes (2)

  • Treatment-related toxicity

    Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy.

  • Local recurrence rate (LRR)

    3, 6, 12, 24 months after radiotherapy

Study Arms (2)

26Gy/5f online adaptive radiotherapy

EXPERIMENTAL

The CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy.

Radiation: Ultrafractionated Radiation Treatment

43.5Gy/15f online adaptive radiotherapy

ACTIVE COMPARATOR

The CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy.

Radiation: Moderate hypofractionated Radiation Treatment

Interventions

Moderate hypofractionated Radiation TreatmentRADIATION

The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy.

43.5Gy/15f online adaptive radiotherapy
Ultrafractionated Radiation TreatmentRADIATION

The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy.

26Gy/5f online adaptive radiotherapy

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, aged ≥35 years, \<70 years
  • ECOG score: 0-2
  • Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection
  • Pathologically confirmed primary breast cancer
  • For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1
  • Indicated for postoperative adjuvant radiotherapy, planned to undergo postoperative adjuvant radiotherapy
  • Able to cooperate and tolerate the treatment

You may not qualify if:

  • Pathologically confirmed metastasis in supraclavicular or infraclavicular lymph nodes, or distant metastasis
  • History of radiotherapy to the neck or chest
  • Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.)
  • History of malignant tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Xiaorong Hou, MD

CONTACT

+86-13811963013hxr_pumch@163.com

Xiaorong Hou

CONTACT

+86-13811963013hxr_pumch@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 23, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 20, 2026

Record last verified: 2026-02

Locations

CN(1)